Job Description
Compliance Specialist required for a leading Biopharma facility in Carlow, to provide compliance support for the SCM/Warehouse/Weigh and Dispense, Receipt documents, Shipping documents, protocols/reports to ensure processes and end products comply with corporate and regulatory requirements to facilitate material handling. Initially an 11 month contract. Please contact Claire Role: Ensures SCM/Warehouse/Weigh and Dispense documentation practices are compliant with site specific and regulatory requirements. Work as directed by the Warehouse & Weigh and Dispense Area Manager(s) according to Company safety policies and cGMP. Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. Provide support for the SCM/Warehouse/Weigh and Dispense with respect to the following: Support the updating of Standard Operating Procedures, Shipping & Receipt Documents, protocols and associated reports and any other documentation/ administration of these documents in direct support to the SCM/Warehouse/Weigh and Dispense. Review of eLogs Archiving/retrieval of the SCM/Warehouse/Weigh and Dispense documentation. Maintaining and controlling the SCM/Warehouse/Weigh and Dispense documentation areas. Acts as compliance point of contact for all SCM/Warehouse/Weigh and Dispense documentation topics. Assist in the review of SCM/Warehouse/Weigh and Dispense operational procedures, training materials and procedures for various systems. Support documentation in support of investigations, non-conformances, protocols, reports and change controls. Assist in the review of data for periodic reviews as required. Drive continuous improvement for all aspects of documentation control/ archival. Contribute to the achievements of department productivity and quality goals. Provide support with audit/inspection requirements to ensure department compliance/readiness. Liaise with site QA Document Control group. Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections. Participate in SCM/Warehouse/Weigh and Dispense Tier daily meetings and ensure effective communication of relevant information. Completion of Projects in an efficient and timely manner as agreed with the area manager. Requirements: Bachelors Degree with 3+ years experience in Pharma and Compliance 3-5 years experience in a quality role (QC/ QA), ideally in a pharmaceutical manufacturing environment Knowledge of cGMP and GDP preferred Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Extensive knowledge of the following systems: Change Control Deviation Management Self-Inspections Knowledge of cGMP and GDP required. Report, standards, policy writing skills required. Skills: Compliance Specialist Quality Pharmaceutical